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IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF DELAWARE

AMARIN PHARACEUTICALS
IRELAND LIMITED,
Plaintiff,
v.
OMTHERA PHARMACEUTICALS, INC.
and ASTRAZENECA
PHARMACEUTICALS LP,
Defendants.

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Civil Action No. 14-791-GMS

ORDER
WHEREAS, the plaintiff, Amarin Pharmaceuticals Ireland Limited ("Amarin"), filed the
instant action against Omthera Pharmaceuticals, Inc. and AstraZeneca Pharmaceuticals LP
(collectively, "the defendants") on June 20, 2014 (D.I. 1);
WHEREAS, the defendants filed a Motion to Dismiss (D.I. 9) on July 14, 2014;
WHEREAS, on August 4, 2014, Amarin filed an Answering Brief in Opposition to the
defendants' Motion to Dismiss (D.I. 13) and, on August 18, 2014, the defendants filed a sealed
Reply (D.I. 16);
WHEREAS, on August 25, 2014, Amarin filed a Motion to Strike and Motion for Leave
to File Surreply (D.1. 18);
WHEREAS, on September 11, 2014, the defendants filed an Answering Brief in
Opposition to Amarin's Motion to Strike (D.I. 21) and, on September 19, 2014, Amarin filed a
Reply (D.I. 23); and
WHEREAS the court has considered the parties' briefing and the applicable law;

IT IS HEREBY ORDERED THAT:

1. The defendants' Motion to Dismiss (D.I. 9) is GRANTED; 1 and

Amarin seeks a declaratory judgment that the defendants' Epanova product infringes U.S. Patent No.
8,663,663 (the "'662 patent"). (D.I. 1.) Amarin asserts that the action is ripe for judicial review because Epanova
is approved by the FDA and is currently being marketed by the defendants. (D.I. 13 at 7.) Further, Amarin alleges
that the Epanova's composition, indication, and product labeling are final and fixed. (Id.)
The defendants assert that dismissal is proper under Fed. R. Civ. P. 12(b)(l) because Amarin's declaratory
judgment action for future inducement and contributory patent infringement is not ripe where Epanovahas not been
launched and launch is not imminent. (D.I. 10 at 5.) In the alternative, the defendants request that the court exercise
its discretion and decline to exercise jurisdiction over the action at this time. (Id.)
The Declaratory Judgment Act provides that "[i]n a case of actual controversy within its jurisdiction, ... any
court of the United States, upon the filing of an appropriate pleading, may declare the rights and other legal relations
of any interested party seeking such declaration, whether or not further relief is or could be sought." 28 U.S.C.
220l(a). An action for declaratory judgment presents a justiciable controversy when "the facts alleged, under all the
circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient
immediacy and reality to warrant the issuance of a declaratory judgment." Medimmune, Inc. v. Genentech., 549 U.S.
118, 127 (2007).
Amarin bears the burden of proving the existence of an Article III case or controversy. See Arkema Inc. v.
Honeywell Intern., Inc., 706 F.3d 1351, 1356 (Fed. Cir. 2013) (citation omitted). In order to detennine an action is
"ripe" the court must evaluate "both the fitness of the issues for judicial decision and the hardship to the parties of
withholding court consideration." See Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 1294-94 (Fed.
Cir. 2008) (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 149 (1967)).
This is not the first time the court has been faced with this issue and these parties. Amarin filed an initial
Complaint in the District of Delaware on March 4, 2014. (See C.A. 14-279-GMS, D.I. 1.) The defendants moved to
dismiss the case under substantially the same reasoning as submitted here. (See id. at D.I. 9.) On May 16, 2014,
Amarin filed an Amended Complaint as a result of Epanova's May 6, 2014 approval by the Food and Drug
Administration ("FDA"). (Id. at D.I. 15.) The court held a scheduling teleconference with the parties on June 16,
2014 during which time the pending Motion to Dismiss was discussed. (See id. at D.I. 23.) Shortly thereafter, on
June 20, 2014, the instant action was filed by Amarin. (D.I. 1.) On June 27, 2014, Amarin filed a Notice of Voluntary
Dismissal in the 14-279 action. (C.A. 14-279-GMS, D.I. 21.) Amarin's filing of the instant action was understood
by the court as an attempt to cure defective jurisdiction in its original Complaint; specifically, the fact that EpanovaTM
had not yet been approved by the FDA at the time of the original filing. While the court finds that FDA approval of
Epanova does provide some amount of support for Amarin's position it is not dispositive.
A declaratory judgment plaintiff must allege "significant, concrete steps to conduct infringing activity." See
Cat Tech LLC v. TubeMaster, Inc., 528 F.3d 871, 880 (Fed. Cir. 2008). In Arkema Inc. v. Honeywell Intern., Inc., the
Federal Circuit found that the declaratory judgment plaintiff had "concrete plans" to supply a product for concededly
infringing uses when it had already marketed the product, had responded to supply requests, and wished to enter
supply contracts with customers. 706 F.3d 1351, 1357 (Fed. Cir. 2013). For purposes of this Order, the court accepts
Amarin's assertion that marketing efforts for the accused product are ongoing. Recognizing that evaluating
justiciability in patent cases is a very fact-dependent exercise, the court detennines that the defendants' advanced
marketing of the accused product is insufficient to meet Amarin's burden in this specific instance. See Matthews Int'!
Corp. v. Biosafe Eng'g, LLC, 695 F.3d 1322, 1328 (Fed. Cir. 2012) ("In detennining whether a justiciable controversy
is present, the analysis must be calibrated to the particular facts of each case.").
The claims at issue in the '662 patent are limited to method of use claims. "Infringement of a method claim
occurs when a party perfonns all of the steps of the process .... " See Ricoh Co. v. Quanta Computer Inc., 550 F.3d
1325, 1333 (Fed. Cir. 2008) (citation omitted). The defendants argue that the alleged acts of infringement of the
patent's method claims "turn on physiological responses that have not occurred, in patients that do not yet exist,
operating under the care of unidentified doctors, who have not yet prescribed a drug that is not yet on the market" and
carmot, therefore, provide the requisite immediacy. (See D.I. 10 at 5.) The court agrees and concludes that any

2. Amarin's Motion to Strike and Motion for Leave to File Surreply (D.I. 18) is
DENIED as Moot.

Dated: November

1'7, 2014

judicial determination as to whether EpanovaTM could infringe the method claims would constitute an advisory
opinion. See Arctic Corner, Inc. v. United States, 845 F.2d 999, 1000 (Fed. Cir. 1998) ("At the heart of the 'case or
controversy' requirement is the prohibition against advisory opinions."). The Federal Circuit came to the same
conclusion in Matthews even after the accused products had been sold. See 695 F.3d at 1330. Here, as in Matthews,
it is unclear when any "even arguably infringing activity will occur." Id As such, the dispute lacks the immediacy
necessary to support the exercise of declaratory judgment jurisdiction. Id (citation omitted).
Amarin alleges that withholding consideration of the Complaint will have an immediate and substantial
impact on the company and that its only recourse is the speedy resolution of this action on the merits. (D.I. 13 at 18.)
In addition, Amarin asserts that "[a]lthough Defendants tell this Court that Epanova's launch date is 'uncertain'
(D.I. 10 at 5), they have made no representations that they will not sell the accused product within the timeframe of
this lawsuit." (D.I. 13 at 10.) While it is possible that Epanova could enter the market within the "timeframe of
this lawsuit" the court does not find that assertion sufficient to prove launch of the product is imminent. It is not
unreasonable to expect that this case could take two years to bring to trial. As the product's launch date remains
uncertain, any potential future infringement is not sufficiently immediate to support the exercise of declaratory
judgment jurisdiction. Moreover, the defendants specifically advised Amarin's counsel that the Epanova product
would not be launched in 2014 and offered to provide notice to Amarin before any controversy could have been
imminent. (See D.I. 13 at 5 n.3.) The court is persuaded by the defendants' representations to provide notice to
Amarin prior to product launch. The court relies on those representations to defeat Amarin's declaratory judgment
claims and, as a result, those representations are binding as a matter of judicial estoppel. See Organic Seed Growers
and Trade Ass'n v. Monsanto Co., 718 F.3d 1350, 1358 (Fed. Cir. 2013).
The court concludes that Amarin has not satisfied the case or controversy requirement and, therefore, finds
dismissal of the case is warranted.